Conventional procedures utilizing conventional instruments for irradiative treatment of the genital tract of patients with carcinoma of the cervix and uterus are complex and time consuming. The most common conventional treatment method includes utilization of what is known in the trade as the Fletcher-Suit after-loading applicator and Delclos after-load mini-ovoids. The placement of the applicator ovoid in relation to the tandem is time consuming and difficult especially in patients with narrow vaginas or a distorted anatomy. Also X-rays are required during surgery after placement of the applicator to check its correct placement, and the patient requires bed rest with minimal motion during the duration of the irradiation treatment (usually two to three days). Motion of the patient in bed may displace the applicator, which requires a return to the operating room for correct replacement. Also the frequency of checking the placement of the irradiative sources exposes the hospital personnel to an undesired frequency of exposure to the radiation. While an experienced physician can properly place a Fletcher-Suit applicator in a patient with normal anatomy in 15-30 minutes, because the skills necessary can be acquired only through extensive training, procedures as long as 31/2 hours for correct placement of the applicator have been required, with corresponding increased time that the patient is under anesthesia and with corresponding increased risk to the patient.
The instrument, and method, according to the present invention overcome most of the disadvantages associated with conventional procedures for treatment of patients with carcinoma of the cervix and uterus. The intravaginal applicator according to the present invention is constructed so that no packing of the vagina is required, saving anesthesia time. Further, suturing of the applicator to the patient at the vaginal introitus ensures that the applicator will remain in proper position despite normal movements of the patient in bed during the duration of the irradiative treatment so that constant checking and/or re-placement of the applicator are usually avoided. Additionally, the location of the irradiative material - in practicing the invention - is extremely precise, and minimizes the chance of involvement of the vaginorectal septum, with corresponding minimized risk of complication. Also, the method according to the invention is much simplified compared to normal procedures, providing simplified training of medical personnel, and minimized placement times.
The instrument according to the present invention includes a tandem having a curved proximate end. The terms "proximal" and "distal" as used in the present specification and claims are relative to the patient's genital tract. That is a "proximal" position is closer to the area to be treated in the genital tract, while a "distal" location is closer to the vaginal introitus (entrance).
The instrument according to the invention also includes an intravaginal applicator. The applicator is preferably quadrate in cross-section, having rounded corners, and has a bore formed along the dimension of elongation thereof for receipt of the tandem. The bore is preferably slightly closer to the anterior surface of the applicator than the posterior surface thereof, to minimize the probability of involvement of the vaginorectal septum. The terms "anterior" and "posterior" as used in the present specification and claims are also relative to the patient's genital tract. Thus an anterior location is closer to the front of the patient's body, while a posterior location is closer to the rear of the patient's body (e.g. rectum).
The applicator includes a slanted proximate end so that the posterior surface thereof is slightly longer than the anterior surface thereof. A pair of cavities are formed in the applicator adjacent the proximate end thereof, one disposed on either side of the tandem-receiving bore. A passageway extends from an opening at the distal end of the applicator adjacent the posterior surface thereof to the opening of each cavity, adjacent the anterior surface and proximal end of the applicator. After-loading of the system is accomplished by inserting a container of irradiative material in each cavity, insertion being accomplished utilizing a handle connected by a flexible hinge connection to each container.
A keel, or like means, is provided for preventing relative rotation between the applicator and tandem, and suture-receiving openings are formed at the distal end of the applicator. During the operative procedure inserting the applicator, sutures are provided at the vaginal introitus, and those sutures are operatively connected to sutures received by the applicator openings to thereby positively hold the applicator in place.
Subsequent to after-loading of the applicator with the irradiative material, a cap is operatively attached to the applicator, closing off the opening at the distal end thereof, and receiving the tandem therein.
It is the primary object of the present invention to provide a simple and effective instrument and method for facilitating the treatment of patients with carcinoma of the cervix and uterus, or like conditions. This and other objects of the invention will become clear from an inspection of the detailed description of the invention, and from the appended claims.